Navigation Links
KV Provides Update on Gestiva(TM) PDUFA Date
Date:10/20/2008

Expected Launch Timing Remains Unchanged

ST. LOUIS, Oct. 20 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company (NYSE: KVa/KVb) announced today that it was advised by Hologic, Inc., the holder of the New Drug Application (NDA) for Gestiva(TM), that the U.S. Food and Drug Administration (FDA) has extended the PDUFA date on Gestiva(TM) for ninety days from October 24, 2008 to January 25, 2009. The ninety-day extension is in line with the FDA's standard operating procedure when it receives updated data from the applicant seeking the NDA.

Under the terms of the previously announced agreement, KV will acquire ownership of the Gestiva(TM) NDA from Hologic upon payment of KV's final milestone payment of $72.5 million that will become due upon FDA marketing approval for the product and KV's receipt of adequate commercial launch quantities.

KV reiterates that the revised PDUFA date is not expected to impact KV's plans regarding the timing of the launch of Gestiva(TM) during the second half of fiscal 2009.

About KV Pharmaceutical Company

KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its branded drug subsidiary.

For further information about KV Pharmaceutical Company, please visit the company's corporate website at http://www.kvpharmaceutical.com.

Safe Harbor

The information in this release may contain various forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 ("PSLRA") and which may be based on or include assumptions concerning KV's operations, future results and prospects. Such statements may be identified by the use of words like "plans", "expect", "aim", "believe", "projects", "anticipates", "commit", "intend", "estimate", "will", "should", "could" and other expressions that indicate future events and trends.

All statements that address expectations or projections about the future, including without limitation, product development, product launches, regulatory approvals, market position, acquisitions, revenues, expenditures and other financial results, are forward-looking statements.

All forward-looking statements are based on current expectations and are subject to risk and uncertainties. In connection with the "safe harbor" provisions, KV provides the following cautionary statements identifying important economic, political and technology factors, which among others, could cause actual results or events to differ materially from those set forth or implied by the forward-looking statements and related assumptions.

Such factors include (but are not limited to) the following: (1) changes in the current and future business environment, including interest rates and capital and consumer spending; (2) the difficulty of predicting FDA approvals such as the Gestiva(TM) NDA discussed above, including timing, and that any period of exclusivity may not be realized; (3) acceptance and demand for new pharmaceutical products; (4) the introduction and impact of competitive products and pricing, including as a result of so-called authorized-generic drugs; (5) new product development and launch, including the planned launch of Gestiva(TM), including the possibility that any product launch, including such launch of Gestiva(TM), may be delayed or that product acceptance may be less than anticipated; (6) reliance on key strategic alliances; (7) the availability of raw materials and/or products manufactured for the Company under contract manufacturing arrangements with third parties; (8) the regulatory environment, including regulatory agency and judicial actions and changes in applicable law or regulations; (9) fluctuations in revenues; (10) the difficulty of predicting international regulatory approval, including timing; (11) the difficulty of predicting the pattern of inventory movements by the Company's customers; (12) the impact of competitive response to the Company's sales, marketing and strategic efforts, including the introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries; (13) risks that the Company may not ultimately prevail in litigation, including challenges to our intellectual property rights by actual or potential competitors or to our ability to market generic products due to brand company patents and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company or its subsidiaries including without limitation the litigation and claims referred to in Note 16 of the Notes to the Consolidated Financial Statements in the Company's Form 10-Q for the quarter ended June 30, 2008; (14) actions by the Internal Revenue Service with respect to the Company's stock option grants and accounting practices; (15) the possibility that KV's current estimates of the financial effect of certain previously announced product recalls could prove to be incorrect; (16) whether any product recalls or product introductions results in litigation, agency action or material damages; (17) the possibility that the findings of the Audit Committee inquiry referenced in the Company's Form 10-Q for the quarter ended June 30, 2008, could have a material impact on the Company's financial results; (18) the satisfaction or waiver of the other closing conditions in the Gestiva(TM) acquisition agreement in addition to those noted above; and (19) the risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. This discussion is by no means exhaustive, but is designed to highlight important factors that may impact the Company's outlook. We are under no obligation to update any of the forward-looking statements after the date of this release.


'/>"/>
SOURCE KV Pharmaceutical Company
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Young Innovations, Inc. Provides Third Quarter Conference Call Details
2. HealthGrades Expects Third Quarter Revenue of Approximately $10 Million : Full-Year 2008 Ratings and Advisory Revenue to Be $39 Million to $40 Million Company Provides Update on Stock Repurchase Program
3. Cardiome Provides Regulatory Update
4. Enjoy Life Foods Teams with AllergyMoms.com to Ensure Halloween Isn't 'Tricky' for Food-Allergic Kids and Families : Provides tips for being allergy-aware this Halloween
5. Seamobile Provides Foxnews To Mercy Ships
6. Major study of opiate use in childrens hospitals provides simple steps to alleviate harm
7. SecureWorks Provides Solutions to Help with Payment Card Industry (PCI) Data Security Standard (DSS) Version 1.2
8. Quality Healthcare Provides Children Kidney Screening Package
9. Songbird Hearing Provides Revolutionary Alternative for Those Dealing With Hearing Loss
10. PeopleClick, LLC Provides Cutting-Edge Servicing to Parents and Families
11. New Book Provides Brutally Honest, Touching & Funny Essays about Women in Their 40s
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/28/2017)... (PRWEB) , ... March 28, 2017 , ... Public relations ... and across a variety of business channels. , While many results are clear, much ... public relations program. , When it comes to measurement, firms should always take ...
(Date:3/28/2017)... ... , ... With expansion and efficiency in mind, Patten Seed Company completed relocation ... plant opened in Marshallville in 2006, and a bagging and shipping facility has been ... of Patten Seed operations to the Middle Georgia location from their previous home in ...
(Date:3/28/2017)... ... ... common and unwelcomed occurrence in people of all ages, genders and ethnicities. Dermatologist Dr. Sonoa ... dealing with excess skin oil. “Oily skin is a challenge to many of my patients. ... oily shine while keeping the skin fresh and clean,” says Dr. Au. , What causes ...
(Date:3/28/2017)... ... March 28, 2017 , ... Nurse ... profession as their value increases in the healthcare workforce, according to a survey ... job boards, career fairs, and candidate leads to healthcare employers of physicians and ...
(Date:3/28/2017)... ... 28, 2017 , ... Bacteria and fungi are probably not the first ingredients that come to ... the right microorganisms in your diet can actually improve health outcomes. And the good news ... the topic of a new peer-reviewed paper led by Maria Marco, Ph.D. ...
Breaking Medicine News(10 mins):
(Date:3/28/2017)... TEL AVIV, Israel , March 28, 2017 ... Israel . This new business entity, Emosis Ltd, headquartered in ... research and development of novel assays complementing the mother company existing ... locally support commercialization and sales development of Emosis kits. ... This strategic move starts building ...
(Date:3/28/2017)... 2017 The global surgical ... value of USD 4.5 billion by 2025, according to ... closure of injured tissues post operation is a major ... occur in 3% to 15% of cases and are ... one third of postoperative deaths in patients. Surgical sealants ...
(Date:3/27/2017)... , March 27, 2017 ... better understand Bayer and its partnering interests and activities since ... report provides an in-depth insight into the partnering activity of ... On demand company reports are prepared upon purchase to ensure ... data. The report will be delivered in PDF ...
Breaking Medicine Technology: